Hybrid S70
510(k) K220574
Hybrid S70 is a medical device (FDA Class II; FDA product code EHD, Unit, X-Ray, Extraoral With Timer) made by DigiMed Co., Ltd., cleared under FDA 510(k) K220574 on 22 Apr 2022, active as of 22 Oct 2026.
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK220574 | Date22 Apr 2022 | StatusActive |
Official records
- FDA 510(k) database K220574
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- EHD
- Device class
- Class II
- Regulation
- 21 CFR Part 872.1800
- Advisory committee
- Dental
- FDA decision
- SESE Substantially Equivalent
Devices cleared under K220574
Devices that FDA's GUDID lists as cleared or approved under this submission number. One submission usually covers a whole product family, so the sizes and models are listed here once.
| UDI-DI | Size and differences | |||
|---|---|---|---|---|
| HYBRID S70 1 | 1 | 08800021800106 | — | On the market |
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